EU Representative services
Under the terms of article 19 of the EU Directive 2001/20/EC in order to conduct clinical trials in the European Union, non-EU based sponsors must have a European company as their legal representative.
EU Legal Representation
Clinical Consulting offers contract with Non-EU Sponsors to provide the required legal representative service including the responsibilities of the Sponsor with regards to GCP and regulatory compliance.
The Orphan Medicinal Product Regulation (EC) No 141/2000 requires that the sponsor who is seeking to obtain or having obtained the designation of a medicinal product as an orphan medicinal product must be established in the European Union.
Clinical Consulting acts as a Legal Representative of a sponsor and thanks to its experienced Team submits all relevant documentation to EMA.
Directive 2001/83/EC concerning medicinal products for human use requires for a marketing authorization application the applicant to be established in the EU.
Directive 2001/20/EC includes the requirements for the conduct of clinical trials in the EU. It provides laws, regulations and administrative provisions while conducting clinical trials. Directive is enriched in gudelines which ensure uniform application of the legistlation in Europe. Guidelines specify:
Necessary information taht need to be submitted to competent authorities and ethics committees
Requirements on safety monitoring and adverse reaction reporting
Good Clinical Practice requirements on documentation
Specific requirements on the products and clinical trials
Inspections of competent authorities and the applicable procedures
Guidelines for the application of Clinical Trials Directive can be found here.